Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy

NCT03847779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-11-13

No results posted yet for this study

Summary

Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.

Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.

All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

Conditions

  • Diabetic Neuropathy Peripheral
  • Small Vessel Disease of Diabetes Mellitus
  • Vasodilation
  • Vasoconstriction

Interventions

OTHER

"Rest"

Cutaneous perfusion and vasomotion assessment at rest in supoine position

OTHER

"Exercise"

Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test

OTHER

"Foot lowering"

Cutaneous perfusion and vasomotion assessment after foot lowering

OTHER

"Hyperthermia"

Cutaneous perfusion and vasomotion assessment during hyperthermia

Sponsors & Collaborators

  • University of Avignon

    lead OTHER

Principal Investigators

  • Eric Benamo, MD · Centre Hospitalier Avignon

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847779 on ClinicalTrials.gov